Identity
- Trade Name
- KBL K9S extraSun FDA UDI
- Generic Name
- Ultraviolet tanning device FDA UDI
- Device Name
- The device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended for tanning the human skin of an adult person. FDA UDI
- Model / Reference
- K9S-e-52-9s-2s UP cpi 05 FDA UDI
- Description
- The device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended for tanning the human skin of an adult person. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260489020388 FDA UDI
- 510(k) Number
- K151962 FDA UDI
- FDA Product Code
- LEJ FDA UDI
- GMDN Term
- Ultraviolet tanning device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4635 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ultraviolet tanning device
KBL K9S extraSun by KBL GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultraviolet tanning device.
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- SIGNATURE SERIES — LIGHT SOURCES, INC. · Class II
- RAVE BELIEVE — LIGHT SOURCES, INC. · Class II
- GOLDEN BRONZE / 100-120W — NARVA Lichtquellen GmbH + Co KG. · Class II
- RIO Bronze — NARVA Lichtquellen GmbH + Co KG. · Class II
- REJUVENESSENCE — LIGHT SOURCES, INC. · Class II
Cleared under the same submission
K151962 also covers:
- KBL 4800 alpha extraSun+ — KBL GmbH
- KBL 5600 alpha extraSun+ — KBL GmbH
- KBL 6700 alpha — KBL GmbH
- KBL 6700 alpha — KBL GmbH
- KBL 6800 alpha extraSun+ — KBL GmbH
- KBL 7000 alpha extraSun — KBL GmbH
- KBL 7000 alpha extraSun+ — KBL GmbH
- KBL 7900 alpha extraSun+ — KBL GmbH
- KBL 8000 alpha extraSun — KBL GmbH
- KBL 8000 alpha extraSun+ — KBL GmbH
- KBL K11 Air (Loft) — KBL GmbH
- KBL K5 extraSun — KBL GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- KBL GmbH
Sources (1)
- FDA UDI 08f4c5e1-f3af-4047-8815-9c95f1880650 34 fields · synced May 30, 2026